Real World Efficiency of Trastuzumab in Early Breast Cancer
NCT ID: NCT01894711
Last Updated: 2013-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
2684 participants
OBSERVATIONAL
2010-05-31
2013-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
RESEARCH QUESTIONS / OBJECTIVES
1. Is adjuvant trastuzumab in daily practice effectively used, that is, how and to whom is it given?
2. Is the introduction of trastuzumab in early breast cancer cost-effective for the Netherlands?
To address the research questions (objectives), the following outcome measures will be determined:
CLINICAL OUTCOME MEASURES
1. Actual trastuzumab administration as opposed to planned trastuzumab administration
2. Selection criteria for chemotherapy and trastuzumab in daily practice
3. Immediate and longterm toxicities due to adjuvant treatment, specifically cardiac
4. Disease-free, breast cancer specific, and overall survival in relation to trastuzumab
ECONOMIC OUTCOME MEASURES
5. Volumes and costs of diagnostic tests and therapies including those for (distant) relapse
6. Cost-effectiveness of trastuzumab in clinical trials versus in real world
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Anastrozole and Fulvestrant Compared to Anastrozole as Adjuvant Treatment of Postmenopausal Patients With Breast Cancer
NCT00357110
A Prospective, Randomized Multicenter, Open-label Comparison of Preoperative Trastuzumab Emtansine (T-DM1) With or Without Standard Endocrine Therapy vs. Trastuzumab With Standard Endocrine Therapy Given for Twelve Weeks in Patients With Operable HER2+/HR+ Breast Cancer Within the ADAPT Protocol.
NCT01745965
Evaluation of Drug Activity in Women With Breast Cancer and no Previous Herceptin Treatment
NCT01596530
Different Durations of Adjuvant Anastrozole Therapy After 2 to 3 Years Tamoxifen Therapy in Breast Cancer
NCT00301457
Evaluating the Effect of Candesartan vs Placebo in Prevention of Trastuzumab-associated Cardiotoxicity
NCT00459771
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients with HER2 positive tumors
Patients with HER2 positive tumors treated with trastuzumab or not treated with trastuzumab
Trastuzumab
Treatment with trastuzumab in HER2 positive patients
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Trastuzumab
Treatment with trastuzumab in HER2 positive patients
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Maastricht University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vivianne CG Tjan-Heijnen, MD.
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Centre
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MEC 09-4-075
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.